Akston is developing a subcutaneously administered therapeutic for preventing or delaying the onset of diabetes in pre-diabetic patients who are at high risk (those who display autoantibodies for insulin, GAD65, IA-2, and ZnT8) for developing Type 1 diabetes (T1D). The therapeutic is designed to delete a subset of B-cells that likely play a role in disease development using a patient?s own antibody directed cell cytotoxicity machinery. The work covered in this submission builds on Phase I SBIR results demonstrating disease prevention in mouse models of T1D and Phase II SBIR results demonstrating the manufacturability of the lead product candidate, its safety in non-human primates, and its translatability from mice to human T1D patients. The therapeutic is now ready for clinical trials which will be performed in partnership with one of the leading clinical research centers in the country. Akston has secured a majority of the resources required to submit an investigational new drug (IND) application to FDA. This Phase IIB SBIR proposal to support assay validation and IND-enabling safety studies would fully close the resource gap to complete the first clinical study in T1D patients and secure a commercialization agreement with one of our potential pharma partners. The impacts to public health as a result of this project are potentially significant. Healthcare costs directly attributable to T1D patients currently account for nearly $20 billion annually. In addition to the 1.25 million Americans who currently live with T1D, 40,000 new T1D patients are diagnosed each year, with the rate of newly diagnosed patients < 20 years of age increasing by 23% in just the past decade. If successful, Akston?s therapeutic could lead to a significant reduction in health care costs and possibly free pre-T1D children and teenagers from a lifetime of glucose monitoring and insulin injections.